Date Published: October 31, 2018
Publisher: Public Library of Science
Author(s): Nicole D. Laborde, Jonah Leslie, Emily Krogstad, Neetha Morar, Prisca Mutero, Juliane Etima, Kim Woodrow, Ariane van der Straten, Douglas S. Krakower.
HIV and pregnancy prevention are dual health priorities for women, and particularly in sub-Saharan Africa. Drug-eluting fibers offer a dosage form that combines HIV prevention and contraception, but early understanding of end-user perspectives is critical to avoid misalignment between products being developed and preferred product attributes.
Focus group discussions (FGDs) were conducted in South Africa, Uganda and Zimbabwe, among 55 women who had used vaginal products in previous trials. Participants were given the opportunity to feel a sample of electrospun nanofiber (the fabric), see how it dissolves, and give feedback on shape, size and other attributes. Women were also asked to compare the fabric to vaginal gel and film.
Three key themes regarding the acceptability of the fabric emerged: 1) look and feel of the product undissolved vs. undissolved, 2) expected effect on sex, and 3) convenience and ease of use. Upon being presented with the fabric, women were initially distrustful, seeing it as undesirable for vaginal insertion. Women generally approved of the product once they saw it dissolve. However, they stressed the importance of the product not interfering with sex by altering the vaginal environment. Women also reacted favorably to the perceived convenience of the fabric, particularly with regards to storage and transport, perceived ease of insertion and use, and dosing regimen.
Multipurpose prevention technologies, and nanofibers in particular, should be developed with an eye to minimizing impact on sex while maximizing convenience, and presented in such a way as to emphasize non-abrasiveness and ease of dissolution.
Preventing HIV and unintended pregnancy are dual health priorities for women globally, and particularly in sub-Saharan Africa (SSA) where young women are infected with HIV at almost twice the rate of young men . Suitable multi-purpose prevention technologies (MPTs) that combine HIV prevention and contraception in one delivery form may increase the acceptability and uptake of the combined product. For example, stigma related to HIV and the lack of trust implied in using an HIV prevention method with a partner are barriers to HIV prevention that could be mitigated by dovetailing HIV prevention with contraception [2, 3]. Various factors affect uptake and continuation contraceptive methods in sub-Saharan Africa, including barriers to access, partner influence, fear or experience of side effects, and inconvenience[3, 4]. Available MPTs (e.g., male and female condoms) have not been widely accepted as both men and women indicate that they interfere with sexual pleasure and are associated with mistrust and infidelity [5, 6].
This qualitative pilot “Fabric” Study was conducted in three countries in Africa at sites that were currently or had previously carried out clinical trials of microbicide vaginal gels: Durban, South Africa; Kampala, Uganda; and Harare, Zimbabwe. The study was carried out as a partnership between a bioengineering team developing the fabric and a qualitative research team experienced with end-user studies of vaginally inserted HIV prevention technologies. Each study site ran between 2 and 4 FGDs or small group conversations with 12–20 women per site for a total sample of 55 participants (Table 1). Researchers contacted women from the roster of previous microbicide gel study participants who had given written permission to be re-contacted for future studies and were between the ages of 18 and 49. These women were well qualified to identify salient end-user product attributes of the fabric, based on their prior exposure to vaginally inserted products for HIV prevention through their prior microbicide trial participation.
In this qualitative study among 55 women in sub-Saharan Africa, women indicated their preferences for specific characteristics of a novel MPT formulation, the fabric, such as shape, size, dosing regimen, and duration. Women also compared the potential acceptability of the fabric, to the vaginal gel and VCF. Participants were initially unsure about the look and feel of the fabric before it had been dissolved in water, expressing concerns about how it would dissolve and if it was soft enough to insert. These concerns decreased once participants saw how the fabric dissolved. They expected that once dissolved the fabric would not interfere with sex and stated that the dissolved product looked like a natural fluid. Women wanted a product that would be discreet and convenient, and the fabric met both criteria. Overall women were very interested in the idea of an MPT and wanted a product that is infrequently inserted and that will not raise concerns with their partners.
Women experienced in the use of vaginal products in three sub-Saharan African countries showed interest in MPTs and indicated that an MPT product might help to overcome some issues that HIV prevention in isolation presents. Specifically, they stated that the fabric would be of interest as an MPT because they did not expect it to interfere with sexual experiences and thought it would be discreet and convenient to use. Novel dosage forms will require adequate user education and familiarization to encourage uptake.